Calibrated test equipment (external and internal) is defined by test equipment classes.
test equipment class 1 (external calibration every XY years)
test equipment class 2 (internal inspection every year)
test equipment class 3 (no calibration needed)
All instruments and instrument components are checked for their functional efficiency. Functional Tests are accomplished during production for:
printed boards,
dosing and dispersing units after assembling, and
outsourced items after assembling.

Figure: SOPs for the functional tests (Operational Qualification) of a vacuum extracion unit.
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基本概念 |
| SOP's |
| Life Cycle Model |
| リファレンマテリアル |
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機器検定 |
| 21 CFR Rule 11 |
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サポート |
| バリデーション |
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インフォメーション |
| 文献 |
| ISO |